Chirag Dhar

Clinical Development & Translational Safety

Chirag Dhar,MBBS, MAS, DPM, FAPCR

Physician-scientist advising organizations across biopharma, medtech and diagnostics on clinical development, translational safety, medical monitoring and evidence strategy.

Clinical development strategy grounded in translational science, medical judgment and disciplined evidence interpretation.

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About

Medicine, science and clinical development.

Chirag Dhar, MBBS, MAS, DPM, FAPCR, is a physician-scientist and clinical development consultant whose work brings together medical training, clinical research, translational science and industry clinical development.

Across academic and industry settings, he has worked with biological rationale, nonclinical pharmacology and toxicology, safety, efficacy, biomarkers and clinical data. His approach is evidence-first: clarify what the data support, identify uncertainty and frame the next development question.

Areas of work

Connecting evidence to practical development questions.

Focused support for teams navigating complex scientific, clinical and safety decisions.

01

Clinical Development Strategy

Development plans, study concepts, endpoints, dose/exposure or performance questions, stopping criteria and practical risk-mitigation approaches.

02

Translational Safety

Connecting mechanism, pharmacology, toxicology, biodistribution, product performance, organ-system risk and disease biology to anticipate clinical safety questions.

03

Medical Monitoring and Clinical Safety

Interpreting safety, efficacy, performance, biomarker, eligibility and protocol-deviation data to support clear, timely study decisions.

04

Regulatory and Scientific Evidence

Building coherent evidence narratives across plans, protocols, intended-use questions, investigator materials, clinical summaries and briefing materials—without overstating what the data support.

Experience

Experience across the evidence continuum.

Work connecting translational evidence with clinical development and safety decisions.

His work spans clinical development and evidence strategy across vaccines, mRNA therapeutics, biologics, and cell and gene therapies, including AI/ML-driven biomarker development and the application of biomarkers for safety, efficacy, screening, and treatment response. His publicly disclosed industry affiliations have included PopVax, Biological E., Zumutor Biologics, and InterVenn Biosciences.

Organizations are identified for biographical context only. Their inclusion does not imply endorsement of independent consulting work.

Selected clinical trials

Clinical development across modalities and disease areas.

Clinical trials and prospective studies to which Chirag has contributed.

Showing 8 studies

StageStudyDisease areaTechnologyLocationRegistry
Phase 1Bivalent typhoid and paratyphoid A conjugate vaccineInfectious diseasesConjugate vaccineIndiaCTRI/2025/07/090155
Phase 1Yellow fever vaccine in healthy adultsInfectious diseasesVaccineIndiaCTRI/2025/09/094526
Phase 1Adjuvanted and non-adjuvanted meningococcal conjugate vaccinesInfectious diseasesConjugate vaccineIndiaCTRI/2025/10/096132
Phase 1PVX-001 COVID-19 booster studyInfectious diseasesmRNA-LNP vaccineAustraliaACTRN12626000891325
Phase 1/2Nivolumab, ipilimumab and immunogenic chemotherapy in advanced NSCLCOncologymAbs and chemotherapyUnited StatesNCT04043195
Phase 2Liquid hexavalent pediatric vaccineInfectious diseasesCombination vaccineIndiaCTRI/2024/02/063223
Phase 224-valent pneumococcal conjugate vaccine in infantsInfectious diseasesConjugate vaccineIndiaCTRI/2024/11/076260
Phase 2Osimertinib plus abemaciclib in EGFR-mutant NSCLCOncologySmall-molecule targeted therapiesUnited StatesNCT04545710

Showing 10 studies

StageStudyDisease areaTechnologyLocationRegistry
Phase 2/3Measles-rubella vaccine in infantsInfectious diseasesCombination vaccineIndiaCTRI/2025/11/097159
Phase 3XBB.1.5 COVID-19 vaccine across pediatric and adult age groupsInfectious diseasesRecombinant RBD-subunit vaccineIndiaCTRI/2024/01/061423
Phase 3Liquid hexavalent pediatric vaccineInfectious diseasesCombination vaccineIndiaCTRI/2025/04/085479
Phase 3Adsorbed inactivated poliomyelitis vaccine in infantsInfectious diseasesInactivated vaccineIndiaCTRI/2025/05/086953
Phase 3JN.1 COVID-19 vaccineInfectious diseasesVaccineIndiaCTRI/2025/09/094477
Phase 3POISE-3: perioperative tranexamic acid and blood-pressure-management strategiesCardiometabolicSmall molecule and perioperative strategyGlobal sites including the United States and IndiaNCT03505723
Phase 3ACHIEVE: spironolactone in dialysis-dependent kidney diseaseRenalSmall moleculeGlobal sites including India and CanadaNCT03020303
Phase 3ACT: anti-inflammatory and antithrombotic therapies for COVID-19Infectious diseasesSmall-molecule combinationGlobal sites including India and CanadaNCT04324463
Phase 4PNEUBEVAX-14 in participants aged five years and olderInfectious diseasesConjugate vaccineIndiaCTRI/2025/03/083102
Phase 4ENRICH-AF: edoxaban after intracranial hemorrhage in atrial fibrillationCardiometabolicSmall-molecule anticoagulantGlobal sites including the United States and IndiaNCT03950076

Showing 6 studies

StageStudyDisease areaTechnologyLocationRegistry
ProspectiveVOCAL ovarian-cancer liquid-biopsy validationOncologyAI/ML-enabled glycoproteomic diagnosticUnited States, Australia, Malaysia and PhilippinesNCT03837327
ProspectiveNICE blood-based detection of colorectal cancer and advanced adenomasOncologyAI/ML-enabled glycoproteomic diagnosticUnited StatesNCT05445570
ProspectivePleural effusion–based diagnostics for targeted therapies in NSCLCOncologyCompanion diagnostics for small-molecule TKIsIndiaInvestigator initiated
ProspectiveNewly diagnosed, treatment-naive HIV and/or tuberculosis cohortInfectious diseasesAI/ML-enabled diagnostics and immunology biomarkersIndiaInvestigator initiated
InterventionalDawn clinical-utility study in advanced or metastatic NSCLCOncologyAI/ML-enabled glycoproteomic diagnosticUnited StatesNCT05603299
Long-term follow-upSafety follow-up after three doses of PNEUBEVAX-14Infectious diseasesConjugate-vaccine safety follow-upIndiaCTRI/2024/07/071627

Studies are drawn from public registries and institutional disclosures. Inclusion describes professional experience and does not imply sponsor endorsement.

Selected scholarship

Research across mechanistic, translational and clinical evidence.

Complete Scholar profile
2026The Lancet Regional Health – Southeast AsiaImmunogenicity and safety of Biological E’s 14-valent pneumococcal conjugate vaccine (PNEUBEVAX 14®) administered in a 2p + 1 schedule to healthy infants2025The Lancet Regional Health – Southeast AsiaSafety and immunogenicity of booster doses of an XBB.1.5 RBD subunit COVID-19 vaccine among individuals aged 5–80 years in India2024British Journal of CancerDiagnosing and staging epithelial ovarian cancer by serum glycoproteomic profiling2021Proceedings of the National Academy of SciencesSialoglycan recognition is a common connection linking acidosis, zinc, and HMGB1 in sepsis2019Frontiers in ImmunologyFrom ‘Serum Sickness’ to ‘Xenosialitis’: Past, Present, and Future Significance of the Non-human Sialic Acid Neu5Gc
Beyond Work

Away from the desk, Chirag plays squash and pickleball, swims the open-water route between La Jolla Cove and the Marine Room, and dives off Neil and Havelock Islands. He also lends a hand restoring a friend’s 1959 Austin-Healey 100-6.

Get in touch

Discuss a clinical development question.

For consulting, advisory or scientific collaboration discussions across biopharma, medtech and diagnostics, please get in touch by email or LinkedIn.

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